MPEP § 2001.06(e) — Information Relating to Regulatory Review (Annotated Rules)
§2001.06(e) Information Relating to Regulatory Review
This page consolidates and annotates all enforceable requirements under MPEP § 2001.06(e), including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Information Relating to Regulatory Review
This section addresses Information Relating to Regulatory Review. Primary authority: 37 CFR 1.56, 37 CFR 11.18(c), and 37 CFR 11.18). Contains: 1 guidance statement, 4 permissions, and 3 other statements.
Key Rules
Material Information Definition
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.
Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for Office review. While the considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is patentable, submissions, particularly any assertion that is made which is contradictory to assertions made to the examiner, may be material to ongoing patent proceedings. Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021). See also MPEP § 2164.05. Duty of disclosure may require that if the actual filing date of an application is after the date of the applicant’s date of marketing approval by FDA, and the applicant intends to list any resulting patent in the orange book for that product, informing the USPTO during examination of the application of that intent and applicant should consider providing the Paragraph IV “factual and legal basis” notice to USPTO.
Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for Office review. While the considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is patentable, submissions, particularly any assertion that is made which is contradictory to assertions made to the examiner, may be material to ongoing patent proceedings. Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021). See also MPEP § 2164.05. Duty of disclosure may require that if the actual filing date of an application is after the date of the applicant’s date of marketing approval by FDA, and the applicant intends to list any resulting patent in the orange book for that product, informing the USPTO during examination of the application of that intent and applicant should consider providing the Paragraph IV “factual and legal basis” notice to USPTO.
Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for Office review. While the considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is patentable, submissions, particularly any assertion that is made which is contradictory to assertions made to the examiner, may be material to ongoing patent proceedings. Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021). See also MPEP § 2164.05. Duty of disclosure may require that if the actual filing date of an application is after the date of the applicant’s date of marketing approval by FDA, and the applicant intends to list any resulting patent in the orange book for that product, informing the USPTO during examination of the application of that intent and applicant should consider providing the Paragraph IV “factual and legal basis” notice to USPTO.
Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021) See also MPEP § 2164.05.
Duty of Disclosure Fundamentals
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.
Scope of Duty
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.
Sanctions for Misconduct
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.
Practitioner Conduct and Certification
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.
Statutory Authority for Examination
Citations
| Primary topic | Citation |
|---|---|
| Duty of Disclosure Fundamentals Material Information Definition Practitioner Conduct and Certification Sanctions for Misconduct Scope of Duty | 37 CFR § 1.56 |
| Duty of Disclosure Fundamentals Material Information Definition Practitioner Conduct and Certification Sanctions for Misconduct Scope of Duty | 37 CFR § 11.18 |
| Duty of Disclosure Fundamentals Material Information Definition Practitioner Conduct and Certification Sanctions for Misconduct Scope of Duty | 37 CFR § 11.18(c) |
| Duty of Disclosure Fundamentals Material Information Definition Practitioner Conduct and Certification Sanctions for Misconduct Scope of Duty | MPEP § 2015 |
| Material Information Definition Statutory Authority for Examination | MPEP § 2164.05 |
Source Text from USPTO’s MPEP
This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.
Official MPEP § 2001.06(e) — Information Relating to Regulatory Review
Source: USPTO2001.06(e) Information Relating to Regulatory Review [R-07.2022]
Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for Office review. While the considerations made by the FDA for approving clinical trials are different from those made by the USPTO in determining whether a claim is patentable, submissions, particularly any assertion that is made which is contradictory to assertions made to the examiner, may be material to ongoing patent proceedings. Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021). See also MPEP § 2164.05. Duty of disclosure may require that if the actual filing date of an application is after the date of the applicant’s date of marketing approval by FDA, and the applicant intends to list any resulting patent in the orange book for that product, informing the USPTO during examination of the application of that intent and applicant should consider providing the Paragraph IV “factual and legal basis” notice to USPTO.
Accordingly, each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office, such as a patent application (including a reissue application), or a reexamination proceeding, the party has a duty to submit the information to the USPTO. 37 CFR 1.56, 1.555, and 11.18(b)(2). A duty of reasonable inquiry may exist based on circumstances known to the party presenting the paper to the USPTO. Failing to inquire when the circumstances warrant it could result in sanctions or other action under 37 CFR 11.18(c), which may include: (1) striking the offending paper; (2) referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) terminating the proceedings in the Office. See, e.g., In re Hao, Proceeding No. D2021-14 (USPTO Apr. 27, 2022) (involving disciplinary sanctions predicated on non-compliance with 37 CFR 11.18). See also MPEP § 2015.